Identification

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Name
Ammonia
Accession Number
DB11118
Type
Small Molecule
Groups
Approved
Description

Ammonia is a naturally-occurring compound with a chemical formula NH3 and structure of trigonal pyramidal geometry. It is a colorless gas with a pungent smell, and become NH4, or ammonium ion, when in water. Although ammonia is used as a food additive in the anhydrous form and serves as a starting material in pharmaceutical and commercial products, it is caustic and hazardous when concentrated. Ammonia gas has been used in the clinical setting as a respiratory stimulant to prevent fainting. The radiolabelled form of ammonia, ammonia N 13, is intravenously administered as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the myocardium to evaluate myocardial perfusion. Ammonia is a natural byproduct of biological and chemical reactions, including decomposition of organic matter, including plants, animals, and animal wastes. It is present in normally present in all tissues constituting a metabolic pool, where it is mostly taken up by glutamic acid and take part in transamination and other reactions, including the synthesis of protein by the Krebs-Hanseleit cycle in the liver 5. It is proposed that human adults produce about 1000 mmol of ammonia daily, most of which undergoes excretion in the urine.

Synonyms
Not Available
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AmmoniaInhalant0.045 g/0.3mLRespiratory (inhalation)Physicians Total Care, Inc.2012-08-172013-01-15Us
Ammonia InhalantsInhalant0.045 g/0.3mLRespiratory (inhalation)X Gen Pharmaceuticals, Inc.1976-02-14Not applicableUs
Ammonia InhalantsInhalant0.045 g/0.3mLRespiratory (inhalation)Sina Health Inc1976-02-14Not applicableUs
Ammonia InhalantsInhalant0.045 g/0.3mLRespiratory (inhalation)A-S Medication Solutions1976-02-14Not applicableUs
Ammonia InhalantsInhalant0.045 g/0.3mLRespiratory (inhalation)Remedy Repack2015-03-242017-03-21Us
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
4010 First Aid KitKit0.045 g/0.3mLTopicalHoneywell Safety Products USA, Inc.2018-10-14Not applicableUs
After Bite Liquid 3.61%LiquidTopicalTender Corporation1990-12-311998-09-11Canada
After Bite OutdoorLiquid3.5 g/100gTopicalTender Corporation2014-11-252016-11-01Us
After Bite The Itch Eraser KIDSLiquid3.5 g/100gTopicalTender Corporation2014-11-252014-11-25Us
After Bite The Itch Eraser XtraLiquid3.5 g/100gTopicalTender Corporation2014-11-252014-11-26Us
After Bite XtraLiquid3.5 g/100gTopicalTender Corporation2014-11-252016-11-01Us
Ammonia InhalantAerosol0.045 g/0.3mLRespiratory (inhalation)Moore Medical LLC2017-11-29Not applicableUs
Ammonia InhalantSwab15 %Respiratory (inhalation)Professional Disposables International, Inc.1980-12-312008-07-08Canada
Ammonia InhalantsInhalant0.05 g/0.33mLRespiratory (inhalation)Dynarex Corporation1976-02-14Not applicableUs
Ammonia InhalantsInhalant0.045 g/0.3mLRespiratory (inhalation)James Alexander Corporation1976-02-14Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

    Learn more
  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
4032 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Lidocaine hydrochloride (24.64 mg/1mL) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4076 First Aid KitAmmonia (0.045 g/0.3mL) + Acetaminophen (325 mg/1) + Benzalkonium chloride (0.13 g/100g) + Benzalkonium chloride (1.3 mg/1mL) + Ethanol (0.5 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Lidocaine hydrochloride (0.5 g/100g) + Neomycin sulfate (3.5 mg/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4121 First Aid KitAmmonia (0.045 g/0.3mL) + Benzalkonium chloride (1.3 mg/1mL) + Benzalkonium chloride (0.13 g/100g) + Lidocaine hydrochloride (0.5 g/100g) + Water (98.6 mL/100mL)KitRespiratory (inhalation)Honeywell Safety Products USA, Inc.2019-01-24Not applicableUs
4125 First Aid KitAmmonia (0.045 g/0.3mL) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzethonium chloride (0.2 g/100g) + Benzocaine (10 g/100g) + Benzocaine (10 g/100g) + Isopropyl alcohol (0.7 mL/1mL) + Levomenthol (0.33 g/100g) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4129 First Aid KitAmmonia (0.045 g/0.3mL) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzocaine (20 g/100g) + Ethanol (0.5 mL/1mL) + Hydrocortisone acetate (1 g/100g) + Isopropyl alcohol (0.7 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Povidone-iodine (10 mg/1mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4133 First Aid KitAmmonia (0.045 g/0.3mL) + Ethanol (0.5 mL/1mL) + Isopropyl alcohol (0.7 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Lidocaine hydrochloride (2 g/100g) + Povidone-iodine (10 mg/1mL) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4135 First Aid KitAmmonia (0.045 g/0.3mL) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Povidone-iodine (10 mg/1mL) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc.2018-09-13Not applicableUs
4139 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Benzalkonium chloride (0.13 g/100g) + Benzalkonium chloride (1.3 mg/1mL) + Lidocaine hydrochloride (0.5 g/100g)KitRespiratory (inhalation)Honeywell Safety Products USA, Inc2018-10-18Not applicableUs
4142 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzocaine (10 g/100g) + Lidocaine hydrochloride (2 g/100g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4154 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Benzalkonium chloride (0.13 g/100g) + Benzalkonium chloride (1.3 mg/1mL) + Lidocaine hydrochloride (0.5 g/100g)KitRespiratory (inhalation)Honeywell Safety Products USA, Inc2018-10-18Not applicableUs
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
4010 First Aid KitAmmonia (0.045 g/0.3mL)KitTopicalHoneywell Safety Products USA, Inc.2018-10-14Not applicableUs
4032 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Lidocaine hydrochloride (24.64 mg/1mL) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4076 First Aid KitAmmonia (0.045 g/0.3mL) + Acetaminophen (325 mg/1) + Benzalkonium chloride (0.13 g/100g) + Benzalkonium chloride (1.3 mg/1mL) + Ethanol (0.5 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Lidocaine hydrochloride (0.5 g/100g) + Neomycin sulfate (3.5 mg/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4121 First Aid KitAmmonia (0.045 g/0.3mL) + Benzalkonium chloride (1.3 mg/1mL) + Benzalkonium chloride (0.13 g/100g) + Lidocaine hydrochloride (0.5 g/100g) + Water (98.6 mL/100mL)KitRespiratory (inhalation)Honeywell Safety Products USA, Inc.2019-01-24Not applicableUs
4125 First Aid KitAmmonia (0.045 g/0.3mL) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzethonium chloride (0.2 g/100g) + Benzocaine (10 g/100g) + Benzocaine (10 g/100g) + Isopropyl alcohol (0.7 mL/1mL) + Levomenthol (0.33 g/100g) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4129 First Aid KitAmmonia (0.045 g/0.3mL) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzocaine (20 g/100g) + Ethanol (0.5 mL/1mL) + Hydrocortisone acetate (1 g/100g) + Isopropyl alcohol (0.7 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Povidone-iodine (10 mg/1mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4133 First Aid KitAmmonia (0.045 g/0.3mL) + Ethanol (0.5 mL/1mL) + Isopropyl alcohol (0.7 mL/1mL) + Lidocaine hydrochloride (20 mg/1mL) + Lidocaine hydrochloride (2 g/100g) + Povidone-iodine (10 mg/1mL) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
4135 First Aid KitAmmonia (0.045 g/0.3mL) + Bacitracin zinc (400 [iU]/1g) + Benzalkonium chloride (1.3 mg/1mL) + Neomycin sulfate (3.5 mg/1g) + Polymyxin B sulfate (5000 [iU]/1g) + Povidone-iodine (10 mg/1mL) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc.2018-09-13Not applicableUs
4139 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Benzalkonium chloride (0.13 g/100g) + Benzalkonium chloride (1.3 mg/1mL) + Lidocaine hydrochloride (0.5 g/100g)KitRespiratory (inhalation)Honeywell Safety Products USA, Inc2018-10-18Not applicableUs
4142 First Aid KitAmmonia (0.045 g/0.3mL) + Acetylsalicylic acid (325 mg/1) + Benzalkonium chloride (1.3 mg/1mL) + Benzethonium chloride (0.2 g/100g) + Benzocaine (10 g/100g) + Lidocaine hydrochloride (2 g/100g) + Water (98.6 mL/100mL)KitTopicalHoneywell Safety Products USA, Inc2018-10-18Not applicableUs
Categories
UNII
Not Available
CAS number
7664-41-7
Weight
Not Available
Chemical Formula
Not Available
InChI Key
Not Available
InChI
Not Available
IUPAC Name
Not Available
SMILES
Not Available

Pharmacology

Indication
  • Indicated for use as a smelling salt to treat or prevent fainting.
  • (when radiolabelled) Indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease Label.
Pharmacodynamics

As a gas, ammonia is a natural byproduct and respiratory stimulant. Its renal metabolism plays a role in whole body acid-base balance.

Mechanism of action

Renal excretion and metabolism of ammonia is critical in regulation of acid-base balance by generating bicarbonate ions and promoting renal net acid excretion, both under basal conditions and in response to acid-base disturbances 4. There is evidence that acute ammonia exposure activates NMDA receptor signalling pathways, and high concentrations of ammonia resulting from urea cycle enzyme deficiencies are associated with changes in astrocyte morphology due to glutamine accumulation, changes in the expression of key astrocyte proteins, and increased concentrations of neuroactive L-tryptophan metabolites 2.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption

Ammonia can be absorbed via oral or inhalation route. Inhales ammonia is temporarily dissolved in the mucus of the upper respiratory tract, however the majority of the gas is released back into the air via expiration 5. In healthy male subjects under exposure to 500 ppm ammonia for 10-27 minutes, about 70-80% of total inspired ammonia was expired 5. In extrahepatic tissues such as the intestine, ammonia is incorporated into nontoxic glutamine and released into blood, where it is transported to the liver for ureagenesis 5.

Volume of distribution
Not Available
Protein binding
Not Available
Metabolism

Healthy hepatocytes detoxify ammonia where hepatic glutaminase, glutamine synthetase and the urea cycle enzymes act as major enzymes for ammonia metabolism. Ammonia is converted to urea in the liver and other tissues. Glutaminase and glutamine synthetase catalyze the condensation of ammonia with glutamate to glutamine, which is a common nontoxic carrier of ammonia 3. In case of hepatic dysfunction or impairment, detoxification capacity decreases and may cause severe pathologies from hyperammonemia, such as hepatic encephalopathy 5.

Route of elimination

It is mainly excreted through expired air or renal elimination 5.

Half life

In normal rat brain, blood-derived ammonia was rapidly converted to glutamine, indicating very short half-life of less than 3 seconds 5.

Clearance
Not Available
Toxicity

LC50 via inhalation in rat is 7338 ppm/1h MSDS. High exposure to ammonia can cause pulmonary edema, which may be life-threatening. Exposure can cause headache, loss of sense of smell, nausea, and vomiting. While mammals has various mechanisms to detoxify and excrete ammonia from the body, death has been reported after an exposure to 10,000 ppm for an unknown duration. Bradycardia was seen at 2,500 ppm, and hypertension and cardiac arrhythmias leading to cardiovascular collapse followed acute exposures to concentrations exceeding 5,000 ppm 5.

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
  1. KESEL RG, O'DONNELL JF, et al.: The biological production and therapeutic use of ammonia in the oral cavity in relation to dental caries prevention. J Am Dent Assoc. 1946 Jun;33:695-714. [PubMed:20996000]
  2. Felipo V, Butterworth RF: Neurobiology of ammonia. Prog Neurobiol. 2002 Jul;67(4):259-79. [PubMed:12207972]
  3. Hakvoort TB, He Y, Kulik W, Vermeulen JL, Duijst S, Ruijter JM, Runge JH, Deutz NE, Koehler SE, Lamers WH: Pivotal role of glutamine synthetase in ammonia detoxification. Hepatology. 2017 Jan;65(1):281-293. doi: 10.1002/hep.28852. Epub 2016 Nov 12. [PubMed:27641632]
  4. Weiner ID, Verlander JW: Ammonia Transporters and Their Role in Acid-Base Balance. Physiol Rev. 2017 Apr;97(2):465-494. doi: 10.1152/physrev.00011.2016. [PubMed:28151423]
  5. Ammonia - National Library of Medicine HSDB Database - Toxnet - NIH [Link]
External Links
PubChem Substance
347911125
Wikipedia
Ammonia
FDA label
Download (264 KB)
MSDS
Download (242 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0CompletedDiagnosticProphylaxis of cardiomyopathy1
2CompletedTreatmentPhenylketonuria (PKU)3
2TerminatedTreatmentMicrovascular coronary artery disease1
4RecruitingDiagnosticN-13 Ammonia Safety1
Not AvailableCompletedDiagnosticCoronary Artery Disease1
Not AvailableRecruitingNot AvailableCoronary Artery Disease1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
KitTopical0.045 g/0.3mL
KitOphthalmic
KitIrrigation
LiquidTopical
LiquidTopical3.5 g/100g
AerosolRespiratory (inhalation)0.045 g/0.3mL
SwabRespiratory (inhalation)15 %
InhalantRespiratory (inhalation)0.045 g/0.3mL
InhalantRespiratory (inhalation)0.05 g/0.33mL
LiquidRespiratory (inhalation)
InhalantRespiratory (inhalation)10 mL/100mL
KitTopical30 mg/1mL
KitOral
InhalantRespiratory (inhalation)0.013 mL/0.3mL
KitTopical
LinimentTopical
LiquidTopical
KitRespiratory (inhalation)
LotionTopical1.5 g/100mL
LiquidTopical20 mg/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Gas
Experimental Properties
PropertyValueSource
melting point (°C)-77.7MSDS
boiling point (°C)-33.4MSDS
Predicted Properties
Not Available
Predicted ADMET features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Taxonomy

Classification
Not classified

Enzymes

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Glutaminase activity
Specific Function
Plays an important role in the regulation of glutamine catabolism. Promotes mitochondrial respiration and increases ATP generation in cells by catalyzing the synthesis of glutamate and alpha-ketogl...
Gene Name
GLS2
Uniprot ID
Q9UI32
Uniprot Name
Glutaminase liver isoform, mitochondrial
Molecular Weight
66322.225 Da
References
  1. Ammonia - National Library of Medicine HSDB Database - Toxnet - NIH [Link]
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Manganese ion binding
Specific Function
This enzyme has 2 functions: it catalyzes the production of glutamine and 4-aminobutanoate (gamma-aminobutyric acid, GABA), the latter in a pyridoxal phosphate-independent manner (By similarity). E...
Gene Name
GLUL
Uniprot ID
P15104
Uniprot Name
Glutamine synthetase
Molecular Weight
42064.15 Da
References
  1. Ammonia - National Library of Medicine HSDB Database - Toxnet - NIH [Link]
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Substrate
General Function
Phospholipid binding
Specific Function
Involved in the urea cycle of ureotelic animals where the enzyme plays an important role in removing excess ammonia from the cell.
Gene Name
CPS1
Uniprot ID
P31327
Uniprot Name
Carbamoyl-phosphate synthase [ammonia], mitochondrial
Molecular Weight
164938.145 Da
References
  1. Ammonia - National Library of Medicine HSDB Database - Toxnet - NIH [Link]

Drug created on December 03, 2015 09:51 / Updated on December 02, 2019 08:57